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In response to COVID-19, some breast cancer trials have temporarily stopped enrolling new patients. Use the contact information in our trial listings to call or email the research site for information about a trial's status.

Visit COVID-19 & Cancer Clinical Trials on Metastatic Trial Talk for regularly updated information about clinical trials during the coronavirus pandemic.

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(Last updated: May 21, 2022)

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NEAREST SITE: 339 miles
The Angeles Clinic and Research Institute
Los Angeles,CA

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT04025216

CAR-T Immunotherapy for Metastatic Triple Negative & ER-Low, HER2- Breast Cancer that is TnMUC1-Positive

A Phase 1 Open-Label, Multi-Center First in Human Study of TnMUC1-Targeted Genetically-Modified Chimeric Antigen Receptor T Cells in Patients With Advanced TnMUC1-Positive Solid Tumors and Multiple Myeloma Scientific Title

Purpose

To study the safety, best dose, side effects (good and bad), and anti-cancer activity of a new CAR-T cell immunotherapy that targets cancer cells that test positive for MUC1.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer that tests positive for the antigen TnMUC1. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®), by IV, once, before the CART-T immunotherapy is given</li> <li class="seamTextUnorderedListItem">CART-TnMUC1, by IV, once</li> </ul> Please contact research site for treatment schedule. May require hospital stay.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">CAR-T is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The cells are removed from your blood, modified with chimeric antigen receptors (CARs) that allow them to attack proteins on cancer cells, and then put back in your body. </li> <li class="seamTextUnorderedListItem">The CAR-T therapy being used in this study trains the immune system to attack MUC1-positive cancer cells. </li> <li class="seamTextUnorderedListItem">Before you have the CAR-T cell therapy, you will be given the chemotherapy drugs fludarabine and cyclophosphamide. These drugs are given to prepare your immune system to receive the CAR-T cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancers that test TnMUC1-positive.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TnMUC1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04025216' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy' target='_blank'>NCI Dictionary of Cancer Terms: CAR T-cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/cellular-therapies-program/car-t-cell-therapy/faq-about-car-t-cell-therapy/' target='_blank'>Dana-Farber Cancer Institute: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tmunity.com/pipeline' target='_blank'>Drug Company Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/MUC1' target='_blank'>Wikipedia: MUC1</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT03696030

CAR T-Cell Immunotherapy in HER2+ Breast Cancer with Brain or Leptomeningeal Metastases

A Phase 1 Cellular Immunotherapy Study of Intraventricularly Administered Autologous HER2-Targeted Chimeric Antigen Receptor (HER2-CAR) T Cells in Patients With Brain and/or Leptomeningeal Metastases From HER2 Positive Cancers Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of a CAR T-cell immunotherapy that is delivered directly into the brain.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer with brain or leptomeningeal metastases. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make your HER2 CAR T-cell therapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">Surgery to place a device (similar to a chemotherapy port) under your scalp</li> <li class="seamTextUnorderedListItem">HER2 CAR T-cells, by injection, weekly, 3 times</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required. Follow up <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Every 2 months for 1 year, then every year for 15 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">CAR T-cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein.</li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack HER2+ cancer cells.</li> <li class="seamTextUnorderedListItem">You will have surgery to insert a device under your scalp so that the CAR T-cell therapy can be infused directly into your brain.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03696030' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cityofhope.org/physician-news/breast-cancer-car-t-cell-therapy' target='_blank'>City of Hope Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy' target='_blank'>NCI Dictionary of Cancer Terms: CAR T-cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/car-t-cell1.html' target='_blank'>American Cancer Society: CAR T-cell Therapy and Its Side Effects</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Leukapheresis' target='_blank'>Wikipedia: Leukapheresis</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Metastases</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope National Medical Center
Duarte,CA

VISITS: May require hospital stay

PHASE: I

NCT ID: NCT04650451

Experimental CAR T-Cell Immunotherapy BPX-603 for Advanced HER2 Positive Breast Cancer

A Phase 1/2, Open-Label, Multicenter, Non-Randomized, Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) In Subjects With Previously Treated Advanced HER2-Positive Solid Tumors Scientific Title

Purpose

To study the safety, best dose and effects (good and bad) of an experimental CAR T-cell immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have no standard of care treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BPX-603 (CAR T-cell immunotherapy), by IV, one time</li> <li class="seamTextUnorderedListItem">Rimiducid, by IV, weekly</li> <li class="seamTextUnorderedListItem">You may also receive, temsirolimus, by IV, one time</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BPX-603 is the experimental CAR T-cell immunotherapy used in this trial.</li> <li class="seamTextUnorderedListItem">CAR T-cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein.</li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack HER2+ cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of HER2 positive cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04650451' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy' target='_blank'>NCI Dictionary of Cancer Terms: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/car-t-cell1.html' target='_blank'>American Cancer Society: CAR T-cell Therapy and Its Side Effects</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04020575

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for MUC 1*

Adoptive Immunotherapy for Advanced MUC1* Positive Breast Cancer With Autologous T Cells Engineered to Express a Chimeric Antigen Receptor, huMNC2-CAR44 Specific for a Cleaved Form of MUC1 (MUC1*) Scientific Title

Purpose

To look at the safety, best dose and effects of an experimental CAR T-cell immunotherapy that targets cancer cells that test positive for MUC1*, a special type of the MUC1 protein.

Who is this for?

People with metastatic (stage IV) breast cancer that tests positive for MUC1 and who have already received at least one standard therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make your personalized CAR T-cell therapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">Chemotherapy to deplete your lymph cells</li> <li class="seamTextUnorderedListItem">huMNC2-CAR44 CAR T-cells, by IV</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR T-cell therapy is a personalized immunotherapy made from your white blood cells. </li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein. </li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack MUC1 on cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04020575' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/treatment-options/car-t-cell-therapy.html' target='_blank'>MD Anderson Cancer Center: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/research/car-t-cells' target='_blank'>NCI: Car T-Cells</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.minervabio.com/clinical-trial-humnc2-car44-in-mbc/' target='_blank'>Minerva Biotechnologies: Study Page</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope National Medical Center
Duarte,CA

VISITS: 10 visits over 13 months, may require 1 hospital stay

PHASE: I

NCT ID: NCT04660929

CAR Immunotherapy for Advanced HER2 Positive Breast Cancer

A Phase 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects With HER2 Overexpressing Solid Tumors Scientific Title

Purpose

To study the safety, side effects and anti-cancer activity of the experimental CAR immunotherapy CT-0508.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make your personalized CAR therapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">CT-0508, by IV, 1 or 3 times, over 1 week</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT-0508 is a CAR immunotherapy made from your own immune cells. </li> <li class="seamTextUnorderedListItem">First, your immune cells are removed from your body during a process called leukapheresis. </li> <li class="seamTextUnorderedListItem">Then the immune cells are modified with chimeric antigen receptors (CARs) so they can attack HER2 proteins on cancer cells.</li> <li class="seamTextUnorderedListItem">Finally, the modified immune cells are then infused back into your body. This part of the trial may include a hospital stay. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of HER2 positive cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04660929' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://carismatx.com/science/' target='_blank'>Carisma Therapeutics Drug Information Page: CT-0508</a> </li></ul>

NEAREST SITE: 948 miles
Sarah Cannon Research Institute at HealthONE
Denver,CO

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05239143

P-MUC1C-ALLO1 CAR-T Cell Immunotherapy for Advanced Breast Cancer

A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of P-MUC1C-ALLO1, an experimental CAR-T cell immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that has progressed on standard treatment. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 CAR-T cell immunotherapy, by IV, 1 session</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 CAR-T cell immunotherapy, by IV, multiple sessions</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li> <li class="seamTextUnorderedListItem">Rimiducid (CaspaCIDe®) may be given for safety</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 is an experimental immunotherapy called CAR-T cell therapy.</li> <li class="seamTextUnorderedListItem">Allogeneic CAR-T cell therapy is an immunotherapy made from donor immune cells.</li> <li class="seamTextUnorderedListItem">Donor immune cells are modified with chimeric antigen receptors (CARs) so they can attack cancer cells.</li> <li class="seamTextUnorderedListItem">Rimiducid (CaspaCIDe®) is an enzyme that can be administered for safety to kill CAR-T cells, if needed.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05239143' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://poseida.com/science/pipeline/#cart-therapies' target='_blank'>Poseida Therapeutics Drug Information Page: P-MUC1C-ALLO1</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/poseida-therapeutics-announces-fda-clearance-of-investigational-new-drug-application-for-p-muc1c-allo1-a-fully-allogeneic-car-t-targeting-multiple-solid-tumors-301447910.html' target='_blank'>Poseida Therapeutics Press Release: P-MUC1C-ALLO1</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bellicum.com/caspacide-safety-switch/' target='_blank'>Bellicum Phamaceuticals Drug Information Page: Rimiducid (CaspaCIDe®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.frontiersin.org/articles/10.3389/fimmu.2020.618427/full' target='_blank'>Journal Article: Allogeneic CAR T-Cell Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

NEAREST SITE: 1643 miles
Texas Children's Hospital
Houston,TX

VISITS: Hospital stay may be required

PHASE: I

NCT ID: NCT03635632

CAR T-Cell Therapy for Advanced Breast Cancer That Tests Positive for GD2

Phase I Study of Autologous T Lymphocytes Expressing GD2-specific Chimeric Antigen and Constitutively Active IL-7 Receptors for the Treatment of Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Solid Cancers (GAIL-N) Scientific Title

Purpose

To study the safety, best dose, anti-cancer activity and side effects (good and bad) of a new CAR-T cell immunotherapy that targets cancer cells that test positive for GD2.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that tests positive for GD2 and who have already received at least two therapies for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make your personalized CAR T-cell therapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®), by IV, at least 24 hours before the CAR T-cell immunotherapy is given</li> <li class="seamTextUnorderedListItem">C7R-GD2 CAR T-cell immunotherapy, by IV</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR T-cell therapy is a personalized immunotherapy made from your white blood cells. The white blood cells are removed from your body and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. These white blood cells are then infused into your body. </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy used in this study trains the immune system to attack cancer cells that test positive for the protein GD2.</li> <li class="seamTextUnorderedListItem">You will receive the chemotherapy drugs cyclophosphamide (Cytoxan®) and fludarabine (Fludara®) before you receive the CAR T-cells. This makes it easier for the CAR T-cells to get into your immune system. </li> <li class="seamTextUnorderedListItem">This study is also enrolling people with other types of advanced cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: GD2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03635632' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcm.edu/research/clinical-trials/h-42207' target='_blank'>Baylor College of Medicine Study Page: GAIL-N</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy' target='_blank'>NCI Dictionary of Cancer Terms: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/treatment-options/car-t-cell-therapy.html' target='_blank'>MD Anderson Cancer Center: T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5458232/' target='_blank'>Journal Article: GD2 Expression in Breast Cancer</a> </li></ul>

NEAREST SITE: 1643 miles
Houston Methodist Hospital
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT02442297

CAR-T Cell Immunotherapy for HER2-Positive Brain Tumors

Phase I Study of Intracranial Injection of T Cells Expressing HER2-specific Chimeric Antigen Receptors (CAR) in Subjects With HER2-Positive Tumors of the Central Nervous System (iCAR) Scientific Title

Purpose

To study the best dose, side effects, and anti-cancer activity of using HER2 CAR-T cell therapy for treating tumors in the central nervous system (CNS).

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the central nervous system (brain or spinal cord). Full eligibility criteria

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Please contact research site for treatment plan. Hospital stay may be required.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The HER2 antibody used in this study is attached to T cells. </li> <li class="seamTextUnorderedListItem">T cells, also called T lymphocytes, are special infection-fighting immune cells present in the blood that can kill other cells, including tumor cells. </li> <li class="seamTextUnorderedListItem">When the HER2 antibody is joined to a T cell it is called a chimeric antigen receptor (CAR) which can target HER2-positive tumor cells.</li> <li class="seamTextUnorderedListItem">These HER2-CAR T cells are an investigational product not approved by the Food and Drug Administration.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02442297' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>

NEAREST SITE: 1643 miles
Baylor St. Luke's Medical Center
Houston,TX

VISITS: May require hospital stay

PHASE: I

NCT ID: NCT03740256

CAR-T Cell Immunotherapy & Immunotherapy Injected Directly into Tumors for Metastatic HER2 Positive Breast Cancer

A First in Human Phase I Trial of Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR T Cells in Patients With Advanced HER2 Positive Solid Tumors Scientific Title

Purpose

To study the safety, anti-cancer activity and other effects (good and bad) of giving a HER2-specific CAR-T Cell immunotherapy and an immunotherapy injected directly into a tumor.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAdVEC, by injection directly into a tumor, one time</li> </ul> followed by <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2-specific CAR-T Cell therapy, by IV, one time</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR-T is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The cells are removed from your blood, modified with chimeric antigen receptors (CARs) that allow them to attack proteins on cancer cells, and then put back in your body.</li> <li class="seamTextUnorderedListItem">CAdVEC is an oncolytic adenovirus--this means it targets and kills cancer cells. It may directly kill cancer cells and stimulate your immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">CAdVEC is injected directly into a tumor. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of HER2 positive cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03740256' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://ncit.nci.nih.gov/ncitbrowser/pages/concept_details.jsf?dictionary=NCI_Thesaurus&version=20.07d&code=C158743&ns=ncit&type=all&key=null&b=1&n=0&vse=null' target='_blank'>NCI Thesaurus: CAdVEC</a> </li></ul>

NEAREST SITE: 1959 miles
Sarah Cannon Research Institute and Tennessee Oncology
Nashville,TN

VISITS: Hospital stay may be required

PHASE: I

NCT ID: NCT05274451

LYL797 CAR T-Cell Immunotherapy for Triple Negative, ROR1 Positive Advanced Breast Cancer

A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR T Cells, in Adults With Relapsed and/or Refractory Solid-Tumor Malignancies Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of LYL797, an experimental type of immunotherapy called CAR T-cell therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), ROR1 positive breast cancer that has progressed on standard treatment. You must not have received T-cell therapy. Full eligibility criteria

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What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LYL797 CAR T-cell therapy</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires 1 biopsy</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LYL797 is an experimental type of immunotherapy called CAR T-cell/CAR-T therapy.</li> <li class="seamTextUnorderedListItem">CAR T-cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The cells are removed from your blood, modified with chimeric antigen receptors (CARs) that allow them to attack proteins on cancer cells, and then put back in your body.</li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack ROR1 positive cancer cells</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of ROR1 positive cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ROR1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05274451' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://lyell.com/our-pipeline' target='_blank'>Lyell Immunopharma Drug Information Page: LYL797</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/cellular-therapies-program/car-t-cell-therapy/faq-about-car-t-cell-therapy/' target='_blank'>Dana-Farber Cancer Institute: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-adoptive-cell-therapy' target='_blank'>Breastcancer.org: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Hospital stay for at least 1 week; follow-up visits for 2 years

PHASE: I-II

NCT ID: NCT02830724

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for CD70

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70 Expressing Cancers Scientific Title

Purpose

To study the safety and effects (good and bad) of using a new type of CAR T-cell immunotherapy.

Who is this for?

People with metastatic (stage IV) breast cancer that tests positive for CD70 who have already received at least one standard therapy. Full eligibility criteria

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What's involved?
What's being studied?
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You will receive the following: Hospital stay (at least 1-week): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells)</li> <li class="seamTextUnorderedListItem">Cyclophosphamide, by IV, once a day, for 2 days</li> <li class="seamTextUnorderedListItem">Fludarabine, by IV, once a day, for 5 days</li> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, 3 times a day, for 3 days</li> <li class="seamTextUnorderedListItem">Anti-hCD70 CAR T-cells, by IV, one time</li> </ul> Post-hospital stay: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibiotic for 6 months</li> <li class="seamTextUnorderedListItem">Repeat Leukapheresis (blood draw for the collection of cells)</li> <li class="seamTextUnorderedListItem">1-2 day hospital visits (for lab tests, imaging studies, and a physical exam), every 1-3 months for the 1st year after treatment, every 6 months for the 2nd year, and then as determined by your doctor</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR T-cell is a personalized immunotherapy made from your white blood cells. </li> <li class="seamTextUnorderedListItem">After your blood cells are removed, they are modified with chimeric antigen receptors (CARs) so they can attack specific proteins. </li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy used in this study is designed to get the immune system to see and kill cancer cells that are CD70+. </li> <li class="seamTextUnorderedListItem">Along with the CAR-T immunotherapy, you will receive the chemotherapy drugs fludarabine and cyclophosphamide. These drugs are given to deplete the lymph cells. </li> <li class="seamTextUnorderedListItem">You will also receive aldesleukin, a drug that stimulates the growth and development of T cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CD70</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02830724' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drsusanloveresearch.org/videos/chimeric-antigen-receptor-t-cell-car-t-therapy' target='_blank'>Dr Susan Love Research Foundation: CAR-T Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/25368676' target='_blank'>Journal Article Abstract: CD70, A Potential Target in Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/search?contains=false&q=Aldesleukin' target='_blank'>NCI Drug Dictionary: Aldesleukin</a> </li></ul>

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Hospital stay for 4-5 weeks

PHASE: II

NCT ID: NCT04102436

CAR T-Cell Immunotherapy for Metastatic Breast Cancer

A Phase II Study Using the Administration of Autologous T-Cells Engineered Using the Sleeping Beauty Transposon/Transposase System to Express T-Cell Receptors Reactive Against Mutated Neoantigens in Patients With Metastatic Cancer Scientific Title

Purpose

To study if an immunotherapy, made from your own white blood cells that are then modified with T-cell receptors, can cause breast cancer tumors to shrink.

Who is this for?

People with metastatic breast cancer that did not respond to the first treatment received. Full eligibility criteria

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What's involved?
What's being studied?
How can I learn more?

You will be in the hospital and receive the following: Before hospital stay: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of cells (leukapheresis)</li> </ul> Hospital stay for receiving treatment (4-5 weeks): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Modified white blood cells (CAR T-cell immunotherapy), by IV</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and Fludarabine (Fludara®), by IV</li> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, once every 8 hours, for up to 10 doses</li> <li class="seamTextUnorderedListItem">Antibiotics</li> <li class="seamTextUnorderedListItem">Filgrastim, by injection</li> </ul> After hospital stay: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Visits approximately 6 and 12 weeks after treatment, then every 3-6 months for 3 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-cells can be modified in a lab to recognize certain changes in the tumor. </li> <li class="seamTextUnorderedListItem">To create the personalized T cells, your white blood cells will be collected and modified in ways that will help them go after your tumor cells. </li> <li class="seamTextUnorderedListItem">These supercharged T cells will then be put into your body. This will be done in the hospital. </li> <li class="seamTextUnorderedListItem">This type of therapy is called CAR T-cell therapy. </li> <li class="seamTextUnorderedListItem">Before you receive the enhanced T cells, you will be treated with the chemotherapy drugs cyclophosphamide (Cytoxan®) and fludarabine (Fludara®). This is to prepare your body to receive the enhanced T cells. </li> <li class="seamTextUnorderedListItem">You will also receive aldesleukin, a drug that enhances immune function and filgrastim, to reduce your risk of developing an infection. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of metastatic cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04102436' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/research/car-t-cells' target='_blank'>NCI Research Article: CAR T Cells, Engineering Patients’ Immune Cells to Treat Their Cancers</a> </li></ul>

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CAR-T Immunotherapy for Metastatic Triple Negative & ER-Low, HER2- Breast Cancer that is TnMUC1-Positive

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CAR T-Cell Immunotherapy in HER2+ Breast Cancer with Brain or Leptomeningeal Metastases

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Experimental CAR T-Cell Immunotherapy BPX-603 for Advanced HER2 Positive Breast Cancer

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CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for MUC 1*

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CAR Immunotherapy for Advanced HER2 Positive Breast Cancer

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P-MUC1C-ALLO1 CAR-T Cell Immunotherapy for Advanced Breast Cancer

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CAR T-Cell Therapy for Advanced Breast Cancer That Tests Positive for GD2

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CAR-T Cell Immunotherapy for HER2-Positive Brain Tumors

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CAR-T Cell Immunotherapy & Immunotherapy Injected Directly into Tumors for Metastatic HER2 Positive Breast Cancer

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LYL797 CAR T-Cell Immunotherapy for Triple Negative, ROR1 Positive Advanced Breast Cancer

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CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for CD70

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CAR T-Cell Immunotherapy for Metastatic Breast Cancer

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